EP2086464B1 - Implantable repair device - Google Patents
Implantable repair device Download PDFInfo
- Publication number
- EP2086464B1 EP2086464B1 EP07854306A EP07854306A EP2086464B1 EP 2086464 B1 EP2086464 B1 EP 2086464B1 EP 07854306 A EP07854306 A EP 07854306A EP 07854306 A EP07854306 A EP 07854306A EP 2086464 B1 EP2086464 B1 EP 2086464B1
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- EP
- European Patent Office
- Prior art keywords
- prosthesis according
- layer
- comprised
- absorbable
- biocompatible
- Prior art date
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- 230000008439 repair process Effects 0.000 title description 3
- 230000007547 defect Effects 0.000 claims abstract description 30
- 230000003014 reinforcing effect Effects 0.000 claims abstract description 30
- 210000001519 tissue Anatomy 0.000 claims abstract description 23
- 239000000463 material Substances 0.000 claims abstract description 16
- 210000003205 muscle Anatomy 0.000 claims abstract description 16
- 239000002131 composite material Substances 0.000 claims abstract description 13
- 230000002093 peripheral effect Effects 0.000 claims abstract description 10
- 230000002787 reinforcement Effects 0.000 claims description 16
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 claims description 6
- 239000000622 polydioxanone Substances 0.000 claims description 6
- 239000004743 Polypropylene Substances 0.000 claims description 5
- -1 polypropylene Polymers 0.000 claims description 5
- 229920001155 polypropylene Polymers 0.000 claims description 5
- 239000004627 regenerated cellulose Substances 0.000 claims description 2
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 claims 1
- 239000007943 implant Substances 0.000 description 10
- 210000001835 viscera Anatomy 0.000 description 7
- 206010019909 Hernia Diseases 0.000 description 5
- 230000004888 barrier function Effects 0.000 description 5
- 230000001936 parietal effect Effects 0.000 description 5
- 239000004744 fabric Substances 0.000 description 4
- 238000007912 intraperitoneal administration Methods 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 210000004872 soft tissue Anatomy 0.000 description 3
- 208000035091 Ventral Hernia Diseases 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 210000003195 fascia Anatomy 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 238000009434 installation Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 206010045458 umbilical hernia Diseases 0.000 description 2
- 206010060954 Abdominal Hernia Diseases 0.000 description 1
- 239000004792 Prolene Substances 0.000 description 1
- 210000003815 abdominal wall Anatomy 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
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- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000001052 transient effect Effects 0.000 description 1
- 238000009827 uniform distribution Methods 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
- A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
Definitions
- the present invention relates generally to implantable prosthesis, and more particularly, to implantable prostheses having particular application for repairing and/or reinforcing an anatomical defect such as a hernia.
- tissue defects such as soft tissue and muscle wall hernias.
- tissue defects such as soft tissue and muscle wall hernias.
- an implantable fabric or mesh patch to cover the opening or defect.
- the patch When an anterior approach is used for the intra-peritoneal ventral hernia repair with a "blind" technique for placing the patch, the patch must be collapsed for passage through the incision and defect, and subsequently released and expanded within the intra-peritoneal space. The patch must then be positioned appropriately, preferably as flat as possible, against the peritoneum.
- the side of the patch facing the viscera has tissue barrier characteristics, such as a barrier layer or film. The proper positioning of the patch, however, has proven to be difficult to do through the central access incision in the defect.
- At least one implantable prosthesis is known to include a strap or the like that is secured to a central location of the patch, and extends from the side of the patch that faces the abdominal wall out through the incision to the exterior of the patient's body.
- This device is described and illustrated in U.S. Patent No. 7,101,381 .
- the strap provides a means by which to pull on the patch once it is inserted in an effort to secure the patch against the parietal wall, thereby occluding the defect.
- the strap is either sewn on or otherwise separately secured to the center of the patch, or is constructed in a manner that requires two separate portions to be secured to the patch as shown in Fig. 7 of the publication. Following final placement of the patch, the straps are secured to adjacent fascia or muscle, such as by suturing, with any excess length being trimmed off.
- this type of device may incorporate a resilient peripheral "ring" to assist in returning the patch to the desired flat configuration following placement, this ring does not significantly prevent the tendency to buckle as described above.
- the disclosed ring is comprised of a non-absorbable material, and thus permanently leaves behind a substantial amount of material within the patient. This can be particularly disadvantageous if the ring should ever fracture, which could cause the rough fractured edge(s) to damage surrounding tissue.
- WO-A-2004012627 describes an implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising: a patch for covering the defect, said patch having a peripheral, annular reinforcing element; and at least one tether that extends from the patch and may be manipulated by the surgeon to position the patch against the defect.
- US-A-20020103494 describes a hernia patch of fabric reinforced with a nitinol, plastic or metal frame.
- a tether may be attached to a central part of the frame.
- WO-A-0007520 describes a hernia patch comprising a non-absorbable mesh patch and a peripheral reinforcing hoop made of bioabsorbable material.
- the present invention provides an implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising: a first biocompatible structure having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect and having a top side, a bottom side; a reinforcement element positioned adjacent the top side of the patch portion and having a top side, a bottom side, and an outer circumferential edge; and second biocompatible structure having a top side and a bottom side and at least one opening therethrough, the at least one opening being substantially centrally located; and the first and second biocompatible structures being secured to one another at least about their respective peripheral edges; characterized in that said first biocompatible structure comprises first and second extension portions, said first and second extension portions extending laterally outward from opposite sides of the central portion and about the outer circumferential edge of the reinforcement element and then inwardly along the top side of the reinforcement element between the reinforcement element and the second biocompatible structure, to a central portion of the reinforcement element, and then outwardly from the central portion
- the present invention provides an implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising: a first composite structure including at least one layer of a non-absorbable material, the first composite structure having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and having an outer periphery; a second structure having an outer peripheral edge; a reinforcing element having an outer periphery positioned between the first and second structures, and having a stiffness greater than that of the first and second structures; wherein the second structure is coupled to the first structure substantially only at their respective peripheries, characterized in that said second structure has a reinforced central region and said prosthesis further comprises at least one pulling element coupled to the reinforced central region of the second structure.
- Prosthesis 100 is a composite prosthesis formed from multiple elements as shown in Fig. 1 , including a first composite structure 115, a reinforcing element 116 (together the "first reinforced structure"), and a second structure 140.
- the first structure 115 has a central portion 115a sized and shaped to cover at least a portion of the tissue or muscle wall defect, and preferably first and second extension portions 126, 127 extending laterally outward from opposite sides of the central portion.
- the first structure further includes a patch member 102 having a top side 101 and a bottom side 103, and a patch portion 104 corresponding in size and shape to central portion 115a.
- patch portion 104 is substantially circular in overall shape, having a diameter D of approximately 4.3 - 6.4 cm, which is suitable for repair of a typical umbilical hernia defect.
- Extending laterally outwardly from opposite sides 105, 106 of the patch portion are first 107 and second 108 extension portions corresponding substantially in size and shape to first and second extension portions 126, 127.
- the patch member preferably comprises a non-absorbable mesh structure, such as the PROLENE TM Soft Mesh, which is a knitted, non-absorbable polypropylene mesh manufactured by Ethicon, Inc. of Somerville, NJ, although any suitable biocompatible material may be used.
- a non-absorbable mesh structure such as the PROLENE TM Soft Mesh, which is a knitted, non-absorbable polypropylene mesh manufactured by Ethicon, Inc. of Somerville, NJ, although any suitable biocompatible material may be used.
- first 109 and second 110 film layers Positioned adjacent the top 101 and bottom 103 sides of the patch portion are first 109 and second 110 film layers respectively, preferably comprised of an absorbable material such as polydioxanone.
- the first layer 109 is approximately 5 ⁇ m (0.002 inches) thick and the second layer 110 is approximately 20 ⁇ m (0.0008 inches) thick.
- a third layer 112 Positioned adjacent a bottom side 111 of the second film layer 110 is a third layer 112, that also preferably is comprised of an absorbable material.
- the absorbable material may be oxidized regenerated cellulose (ORC), having a composition such as that manufactured and sold by Ethicon, Inc. under the name INTERCEDE TM .
- the size and shape of the first, second, and third layers are substantially similar to that of the patch portion 104, and may mimic the patch member as a whole as illustrated for the first and second film layers.
- the components are aligned as shown in Fig. 1 , and then secured together in any suitable manner, such as by bonding by heating the assembly to a temperature of approximately 130 degrees Celsius for approximately 30 seconds, to form the first structure 115.
- the third layer 112 provides a bioresorbable layer that physically separates and protects the non-absorbable polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the polypropylene mesh.
- structure 115 discloses a composite structure that provides an implant with a barrier surface on one side of the implant while providing a second surface intended to incorporate into the parietal wall
- alternate monolithic layers are envisioned which incorporate both functions into one structure.
- One example of such a monolithic structure is produced by W.L. Gore & Associates, a Delaware Corporation, and sold as GORE DUALMESH®.
- first and second extension portions 126, 127 are folded over and sewn or otherwise secured in place to form looped elements 120, 121 as best shown in Fig. 2 .
- a reinforcement element 116 (described in detail below), preferably having a substantially similar size and shape as the patch portion 104, is then aligned adjacent a top surface 113 of the first structure 115 as shown in Fig. 2 .
- the first and second extension portions 126, 127 of the first structure are extended around a circumferential edge 117 of the reinforcement element 116 and over the top side 118 to a central portion 119 of the reinforcing element as shown in Fig. 3 .
- the preferred embodiment of the prosthesis also includes a second structure 140 having an outer periphery 143 and a central region 143a.
- the second structure further includes a second mesh layer 130, third and fourth film layers 132, 134 positioned adjacent top bottom and top 133, 135 sides thereof, and a separate stiffening element 136 in the central region, preferably a film ring, having an outer diameter less than that of film layers 132, 134 and positioned adjacent a bottom side 137 of the third 132 film layer.
- the second mesh layer 130 is preferably made of a synthetic, absorbable material, such as VICRYL TM Mesh, which is prepared from polyglactin 910 and also manufactured and sold by Ethicon, Inc.
- the third and fourth film layers and film ring are preferably comprised of polydioxanone.
- the layers are aligned as illustrated and bonded together to form a second structure 140 having a top side 140a and a bottom side 140b.
- this composite structure may be replaced be a monolithic layer that is formed of varying stiffness regions with the central portion having significantly greater stiffness than the regions near the perimeter of the layer.
- first reinforced structure 129 shown in Fig. 3 and the second structure 140 are then aligned as shown in Fig. 4 so that the first and second loops 120, 121 extend through first and second openings 142, 144 through the second structure 142 as shown in Fig. 5 , and then bonded (i.e., via ultrasonic welding), fused, sewn, or otherwise joined together substantially only around their respective outer peripheries with the exception of extension portions 126, 127 as described below..
- additional grasping elements 150, 151 such as an ETHIBOND TM polyester suture or the like (also manufactured by Ethicon, Inc.), may be inserted through the first and second loops 120, 121 as shown in Fig. 6 .
- film ring 136 is bonded to the second structure 140, but is not bonded to the first reinforced structure. Further, the first and second extension portions 126, 127 are coupled to the film ring 136 of the second structure and are not otherwise secured to the first reinforced structure other than around the peripheral edge.
- This configuration is advantageous in that it enables a centralized force exerted on the first and second loops 120, 121 to be distributed to the film ring 136, and thus distributed substantially uniformly through the second structure 140 and ultimately to the outer periphery 146 of the prosthesis, which is reinforced by the outer circumferential ring 180 of the reinforcement element. This distribution of forces is illustrated in the cross-sectional view of Fig.
- an alternate embodiment could include a single 120a or separate straps that are coupled or secured by any suitable means to a ring element 136a of a second structure 140a as shown in Fig. 15 , or may utilize one or more pulling elements 120b, 121 b or grasping means attached to a substantially solid central element 136b as shown in Fig. 15a . Both embodiments enable the distribution of loading during tensioning, however the embodiment illustrated in figure 15a provides a three dimensional central portion 137a capable of at least partially filling the defect in the fascial plane.
- the reinforcing element 116 serves to reinforce the implant, and maintain its proper substantially flat orientation covering the defect within the patient's body.
- the reinforcing element must be flexible enough to allow it to be collapsed for passage through the incision and defect, but resilient enough to resume the substantially flat configuration once properly placed.
- the element should control, in part or in whole, the direction of strain when subjected to a radial compressive force. Additionally, the reinforcing element must not inhibit tissue incorporation into the tissue support layer and should provide means for the heating tissue to pass through to the tissue support layer.
- the resilient element described and illustrated herein has been found particularly suitable for these purposes, and its preferred three-dimensional configuration greatly improves resistance to collapsing or buckling of the implant after placement.
- the three dimensional form provides the additional benefit of controlling the direction of strain of the implant during placement.
- the first and second loops 120, 121 are pulled on by the surgeon to ensure a proper and tight fit of the implant relative to the defect.
- the force from the user is distributed from the center of the device uniformly to the perimeter of the reinforcing layer thereby creating a radial compressive load in the reinforcing layer.
- the strain in the reinforcing layer is directed towards the center of the device and, in the preferred direction, away from the parietal wall.
- the reinforcing element preferably has a three-dimensional ("three-dimensional" meaning having a third dimension other than simple thickness of a planar structure), somewhat toroidal shape, with an outer circumferential ring 180 of the element lying substantially in a first horizontal plane and an inner circumferential ring 182 lying substantially in a second horizontal plane. Spoke like elements 184 extend therebetween, and in the illustrated embodiment, an intermediate circumferential ring 186 is positioned between the outer circumferential ring 180 and the inner circumferential ring 182.
- the reinforcing element is preferably made of an absorbable material, such as polydioxanone, with a thickness of approximately 0.015 inch which renders its stiffness greater than that of the first or second structures 115, 140.
- it may further include one or more rib-like elements 188 extending longitudinally along portions of the spoke-like elements 184.
- the rib elements further reinforce and provide stability to the implant and prevent permanent inversion of the formed shape from transient compression perpendicular to the plane of the center portion of the three dimensional reinforcing layer.
- the three-dimensional geometry and configuration of the reinforcing element has proven to be superior over two-dimensional geometries in achieving an optimum combination of flexibility, rigidity, resistance to buckling, and controlling the direction of strain for the above-described application.
- Figs. 9-13 illustrate various steps of a method for implanting a prosthesis and not claimed by the present invention.
- the skin and tissue in the area of the defect is dissected to provide access to the surgical site.
- the hernia sac is exposed as illustrated in Fig. 9 , with the sac divided and contents inverted as shown in Fig. 10 .
- the patch 100 is folded over with the side containing the straps on the interior of the fold, and the exposed ORC fabric layer 112 on the exterior of the fold as shown in Fig. 11 .
- the patch 100 is then delivered into the surgical site through the incision 200. This may be done in any suitable manner, including with or without the use of a cannula or trocar to facilitate its passage.
- the patch When the patch is fully within the intra-peritoneal space, the patch is released from its folded configuration so that it resiliently resumes its original, substantially flat configuration. Proper positioning against the internal viscera in the substantially flat configuration (with the ORC fabric layer 112 facing the internal viscera) is further facilitated by pulling slightly on the grasping elements 150, 151. Following suitable placement, loops 120, 121 are secured to the anterior fascia as shown in Fig. 12 , leaving the implanted patch as shown in Fig. 13 .
Abstract
Description
- The present invention relates generally to implantable prosthesis, and more particularly, to implantable prostheses having particular application for repairing and/or reinforcing an anatomical defect such as a hernia.
- Various forms of implantable prostheses have been used for repairing or reinforcing tissue defects, such as soft tissue and muscle wall hernias. For example, it is well known to use an implantable fabric or mesh patch to cover the opening or defect. When an anterior approach is used for the intra-peritoneal ventral hernia repair with a "blind" technique for placing the patch, the patch must be collapsed for passage through the incision and defect, and subsequently released and expanded within the intra-peritoneal space. The patch must then be positioned appropriately, preferably as flat as possible, against the peritoneum. Typically, the side of the patch facing the viscera has tissue barrier characteristics, such as a barrier layer or film. The proper positioning of the patch, however, has proven to be difficult to do through the central access incision in the defect.
- More recently, at least one implantable prosthesis is known to include a strap or the like that is secured to a central location of the patch, and extends from the side of the patch that faces the abdominal wall out through the incision to the exterior of the patient's body. This device is described and illustrated in
U.S. Patent No. 7,101,381 . The strap provides a means by which to pull on the patch once it is inserted in an effort to secure the patch against the parietal wall, thereby occluding the defect. The strap is either sewn on or otherwise separately secured to the center of the patch, or is constructed in a manner that requires two separate portions to be secured to the patch as shown inFig. 7 of the publication. Following final placement of the patch, the straps are secured to adjacent fascia or muscle, such as by suturing, with any excess length being trimmed off. - With devices of this type, excess force exerted on the central portion of the patch by the straps can cause the patch to collapse centrally so that the center of the patch begins to pass through the defect, with the radial portion of the patch buckling outwardly (away from the parietal wall) around it. This is extremely undesirable in that buckled or inverted edges expose the unprotected mesh material (portions without a tissue barrier) directly to the internal viscera, increasing the likelihood of undesirable attachments forming between the mesh and the viscera. Further, the securing of the straps to the central portion of the patch may in and of itself compromise the barrier layer. Thus, it is important in any such device to ensure that the patch remains positioned in a uniform plane against the viscera when pulling on the straps to position it.
- Although this type of device may incorporate a resilient peripheral "ring" to assist in returning the patch to the desired flat configuration following placement, this ring does not significantly prevent the tendency to buckle as described above. Further, the disclosed ring is comprised of a non-absorbable material, and thus permanently leaves behind a substantial amount of material within the patient. This can be particularly disadvantageous if the ring should ever fracture, which could cause the rough fractured edge(s) to damage surrounding tissue.
-
WO-A-2004012627 describes an implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising: a patch for covering the defect, said patch having a peripheral, annular reinforcing element; and at least one tether that extends from the patch and may be manipulated by the surgeon to position the patch against the defect. -
US-A-20020103494 describes a hernia patch of fabric reinforced with a nitinol, plastic or metal frame. A tether may be attached to a central part of the frame. -
WO-A-0007520 - Accordingly, it is an object of the present invention to provide improved implantable prostheses for repairing and/or reinforcing soft tissue or muscle wall defects.
- In a first aspect, the present invention provides an implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising: a first biocompatible structure having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect and having a top side, a bottom side; a reinforcement element positioned adjacent the top side of the patch portion and having a top side, a bottom side, and an outer circumferential edge; and second biocompatible structure having a top side and a bottom side and at least one opening therethrough, the at least one opening being substantially centrally located; and the first and second biocompatible structures being secured to one another at least about their respective peripheral edges; characterized in that said first biocompatible structure comprises first and second extension portions, said first and second extension portions extending laterally outward from opposite sides of the central portion and about the outer circumferential edge of the reinforcement element and then inwardly along the top side of the reinforcement element between the reinforcement element and the second biocompatible structure, to a central portion of the reinforcement element, and then outwardly from the central portion through the at least one opening in the second biocompatible structure.
- In a second aspect, the present invention provides an implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising: a first composite structure including at least one layer of a non-absorbable material, the first composite structure having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and having an outer periphery; a second structure having an outer peripheral edge; a reinforcing element having an outer periphery positioned between the first and second structures, and having a stiffness greater than that of the first and second structures; wherein the second structure is coupled to the first structure substantially only at their respective peripheries, characterized in that said second structure has a reinforced central region and said prosthesis further comprises at least one pulling element coupled to the reinforced central region of the second structure.
-
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Fig. 1 is an exploded view of the components of a preferred embodiment of a prosthesis according to the present invention; -
Fig. 1a illustrates the prosthesis ofFig. 1 partially assembled; -
Figs. 2-5 illustrates the prosthesis ofFig. 1 at various points during assembly; -
Fig. 6 illustrates the prosthesis ofFig. 1 fully assembled; -
Figs. 7-8 are perspective and side views of the reinforcement element of the prosthesis ofFig. 1 ; -
Figs. 9-13 illustrate various steps of a procedure for implanting a prosthesis according to the present invention; -
Figs. 14 and 14b are a cross-sectional views of the embodiment ofFig. 5 ;
and -
Figs. 155 and15a are cross-sectional views illustrating alternative embodiments of a prosthesis according to the present invention. - Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. For example, although the present invention is described in detail as it relates to implantable prostheses for repairing umbilical hernias, it is to be understood that such devices can readily be used for repairing various other soft tissue or muscle wall defects, including but not limited to trocar site punctures, small ventral hernias etc.
- Referring now to
Figs. 1-8 and14a-b , a preferred embodiment of a prosthesis of the present invention will now be described in detail.Prosthesis 100 is a composite prosthesis formed from multiple elements as shown inFig. 1 , including a firstcomposite structure 115, a reinforcing element 116 (together the "first reinforced structure"), and asecond structure 140. Thefirst structure 115 has a central portion 115a sized and shaped to cover at least a portion of the tissue or muscle wall defect, and preferably first andsecond extension portions - The first structure further includes a
patch member 102 having atop side 101 and abottom side 103, and apatch portion 104 corresponding in size and shape to central portion 115a. In the illustrated embodiment,patch portion 104 is substantially circular in overall shape, having a diameter D of approximately 4.3 - 6.4 cm, which is suitable for repair of a typical umbilical hernia defect. Extending laterally outwardly fromopposite sides second extension portions - Positioned adjacent the
top 101 andbottom 103 sides of the patch portion are first 109 and second 110 film layers respectively, preferably comprised of an absorbable material such as polydioxanone. In a preferred embodiment, thefirst layer 109 is approximately 5 µm (0.002 inches) thick and the second layer 110 is approximately 20 µm (0.0008 inches) thick. Positioned adjacent abottom side 111 of the second film layer 110 is athird layer 112, that also preferably is comprised of an absorbable material. The absorbable material may be oxidized regenerated cellulose (ORC), having a composition such as that manufactured and sold by Ethicon, Inc. under the name INTERCEDE™. The size and shape of the first, second, and third layers are substantially similar to that of thepatch portion 104, and may mimic the patch member as a whole as illustrated for the first and second film layers. The components are aligned as shown inFig. 1 , and then secured together in any suitable manner, such as by bonding by heating the assembly to a temperature of approximately 130 degrees Celsius for approximately 30 seconds, to form thefirst structure 115. When implanted, thethird layer 112 provides a bioresorbable layer that physically separates and protects the non-absorbable polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the polypropylene mesh. - While the illustrative embodiment described for
structure 115 discloses a composite structure that provides an implant with a barrier surface on one side of the implant while providing a second surface intended to incorporate into the parietal wall, alternate monolithic layers are envisioned which incorporate both functions into one structure. One example of such a monolithic structure is produced by W.L. Gore & Associates, a Delaware Corporation, and sold as GORE DUALMESH®. - After forming the
first structure 115, the ends of the first andsecond extension portions elements Fig. 2 . A reinforcement element 116 (described in detail below), preferably having a substantially similar size and shape as thepatch portion 104, is then aligned adjacent atop surface 113 of thefirst structure 115 as shown inFig. 2 . The first andsecond extension portions circumferential edge 117 of thereinforcement element 116 and over thetop side 118 to acentral portion 119 of the reinforcing element as shown inFig. 3 . - Referring back to
Fig. 1 , the preferred embodiment of the prosthesis also includes asecond structure 140 having anouter periphery 143 and acentral region 143a. The second structure further includes asecond mesh layer 130, third and fourth film layers 132, 134 positioned adjacent top bottom and top 133, 135 sides thereof, and aseparate stiffening element 136 in the central region, preferably a film ring, having an outer diameter less than that of film layers 132, 134 and positioned adjacent abottom side 137 of the third 132 film layer. Thesecond mesh layer 130 is preferably made of a synthetic, absorbable material, such as VICRYL™ Mesh, which is prepared from polyglactin 910 and also manufactured and sold by Ethicon, Inc. of Somerville, NJ. The third and fourth film layers and film ring are preferably comprised of polydioxanone. The layers are aligned as illustrated and bonded together to form asecond structure 140 having atop side 140a and abottom side 140b. Alternatively, this composite structure may be replaced be a monolithic layer that is formed of varying stiffness regions with the central portion having significantly greater stiffness than the regions near the perimeter of the layer. - The first reinforced
structure 129 shown inFig. 3 and thesecond structure 140 are then aligned as shown inFig. 4 so that the first andsecond loops second openings second structure 142 as shown inFig. 5 , and then bonded (i.e., via ultrasonic welding), fused, sewn, or otherwise joined together substantially only around their respective outer peripheries with the exception ofextension portions grasping elements second loops Fig. 6 . - As indicated,
film ring 136 is bonded to thesecond structure 140, but is not bonded to the first reinforced structure. Further, the first andsecond extension portions film ring 136 of the second structure and are not otherwise secured to the first reinforced structure other than around the peripheral edge. This configuration is advantageous in that it enables a centralized force exerted on the first andsecond loops film ring 136, and thus distributed substantially uniformly through thesecond structure 140 and ultimately to theouter periphery 146 of the prosthesis, which is reinforced by the outercircumferential ring 180 of the reinforcement element. This distribution of forces is illustrated in the cross-sectional view ofFig. 14b , where P denotes the pulling force exerted on theloops Fig. 14a illustrating the device with no pulling forces being exerted on it). This substantially uniform distribution of centralized forces to the outer periphery of the implant provides significant improvements over known devices in the ability to avoid point stresses and potential damage to the implant at the attachment point(s) of the straps, and to implant and correctly place the prosthesis. - The effective redistribution of forces as described above is achieved with the described and illustrated preferred embodiment, but can also be achieved in various other alternative embodiments so long as central straps or other pulling elements are secured to a centrally reinforced second structure that is coupled to the first reinforced structure substantially only about its peripheral edge. For example, an alternate embodiment could include a single 120a or separate straps that are coupled or secured by any suitable means to a
ring element 136a of asecond structure 140a as shown inFig. 15 , or may utilize one or more pullingelements central element 136b as shown inFig. 15a . Both embodiments enable the distribution of loading during tensioning, however the embodiment illustrated infigure 15a provides a three dimensionalcentral portion 137a capable of at least partially filling the defect in the fascial plane. - Referring now to
Figs. 7 and 8 , the reinforcingelement 116 serves to reinforce the implant, and maintain its proper substantially flat orientation covering the defect within the patient's body. The reinforcing element must be flexible enough to allow it to be collapsed for passage through the incision and defect, but resilient enough to resume the substantially flat configuration once properly placed. The element should control, in part or in whole, the direction of strain when subjected to a radial compressive force. Additionally, the reinforcing element must not inhibit tissue incorporation into the tissue support layer and should provide means for the heating tissue to pass through to the tissue support layer. The resilient element described and illustrated herein has been found particularly suitable for these purposes, and its preferred three-dimensional configuration greatly improves resistance to collapsing or buckling of the implant after placement. - The three dimensional form provides the additional benefit of controlling the direction of strain of the implant during placement. During installation and following insertion of the device through the defect, the first and
second loops Fig. 8 , the reinforcing element preferably has a three-dimensional ("three-dimensional" meaning having a third dimension other than simple thickness of a planar structure), somewhat toroidal shape, with an outercircumferential ring 180 of the element lying substantially in a first horizontal plane and an innercircumferential ring 182 lying substantially in a second horizontal plane. Spoke likeelements 184 extend therebetween, and in the illustrated embodiment, an intermediatecircumferential ring 186 is positioned between the outercircumferential ring 180 and the innercircumferential ring 182. The reinforcing element is preferably made of an absorbable material, such as polydioxanone, with a thickness of approximately 0.015 inch which renders its stiffness greater than that of the first orsecond structures like elements 188 extending longitudinally along portions of the spoke-like elements 184. The rib elements further reinforce and provide stability to the implant and prevent permanent inversion of the formed shape from transient compression perpendicular to the plane of the center portion of the three dimensional reinforcing layer. The three-dimensional geometry and configuration of the reinforcing element has proven to be superior over two-dimensional geometries in achieving an optimum combination of flexibility, rigidity, resistance to buckling, and controlling the direction of strain for the above-described application. -
Figs. 9-13 illustrate various steps of a method for implanting a prosthesis and not claimed by the present invention. The skin and tissue in the area of the defect is dissected to provide access to the surgical site. Preferably, the hernia sac is exposed as illustrated inFig. 9 , with the sac divided and contents inverted as shown inFig. 10 . Thepatch 100 is folded over with the side containing the straps on the interior of the fold, and the exposedORC fabric layer 112 on the exterior of the fold as shown inFig. 11 . Thepatch 100 is then delivered into the surgical site through theincision 200. This may be done in any suitable manner, including with or without the use of a cannula or trocar to facilitate its passage. When the patch is fully within the intra-peritoneal space, the patch is released from its folded configuration so that it resiliently resumes its original, substantially flat configuration. Proper positioning against the internal viscera in the substantially flat configuration (with theORC fabric layer 112 facing the internal viscera) is further facilitated by pulling slightly on thegrasping elements loops Fig. 12 , leaving the implanted patch as shown inFig. 13 . - It will be apparent from the foregoing that, while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the scope of the invention as defined in the accompanying claims.
Claims (28)
- An implantable prosthesis (100) for repairing or reinforcing a tissue or muscle wall defect, comprising:a first biocompatible structure (115) having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect and having a top side, a bottom side;a reinforcement element (116) positioned adjacent the top side of the patch portion and having a top side, a bottom side, and an outer circumferential edge; anda second biocompatible structure (140) having a top side and a bottom side and at least one opening (142,144) therethrough, the at least one opening being substantially centrally located; andthe first and second biocompatible structures (115,140) being secured to one another at least about their respective peripheral edges;
characterized in that said first biocompatible structure comprises first and second extension portions (126,127), said first and second extension portions (126,127) extending laterally outward from opposite sides of the central portion and about the outer circumferential edge (117) of the reinforcement element (116) and then inwardly along the top side (118) of the reinforcement element between the reinforcement element and the second biocompatible structure (140), to a central portion (119) of the reinforcement element, and then outwardly from the central portion through the at least one opening (142,144) in the second biocompatible structure (140). - The prosthesis according to claim 1, wherein the reinforcement element (116) has a stiffness greater than a stiffness of the first and second biocompatible structures (115,140).
- The prosthesis according to claim 1 or 2, wherein the reinforcement element (116) further comprises an outer circumferential ring (180) and an inner circumferential ring (182) and a plurality of spoke elements (184) extending therebetween.
- The prosthesis according to claim 3, wherein the outer circumferential ring (180) lies substantially in a first horizontal plane and the inner circumferential ring (182) lies substantially in a second horizontal plane spaced apart from the first horizontal plane.
- The prosthesis according to claim 4, further comprising at least one rib-like element (188) extending outwardly from at least one of the plurality of spoke elements (184).
- The prosthesis according to claim 5, wherein the at least one rib-like element (188) is aligned longitudinally along a length of the at least one spoke element (184).
- The prosthesis according to any preceding claim, wherein distal ends of the first and second extension portions (126,127) are folded over to form first and second looped elements (120,121).
- The prosthesis according to claim 7, further comprising first and second grasping members (150,151) secured to the first and second looped elements (120,121) respectively.
- The prosthesis according to any preceding claim, wherein the first biocompatible structure (115) further comprises: a patch member (102) comprised of a non-absorbable mesh; and first and second absorbable film layers (109,111) positioned adjacent top and bottom sides of the patch member (102) respectively and secured thereto.
- The prosthesis according to claim 9, wherein the patch member (102) is comprised of polypropylene and the first and second film layers (109,111) are comprised of polydioxanone.
- The prosthesis according to claim 9 or 10, wherein the first biocompatible structure further comprises a third layer (112) positioned adjacent to a bottom side of the second film layer (111) and secured thereto.
- The prosthesis according to claim 11, wherein the third layer (112) is comprised of an absorbable material.
- The prosthesis according to claim 12, wherein the third layer (112) is comprised of oxidized regenerated cellulose.
- The prosthesis according to any preceding claim, wherein the second biocompatible structure (140) further comprises a ring element (136) having an outer diameter less than an outer diameter of the second biocompatible structure (140), and wherein the first and second extension portions (126,127) of the first biocompatible structure (115) are coupled to the ring element (136).
- The prosthesis according to any preceding claim, wherein the second biocompatible structure (140) further comprises a mesh layer (130), and third and fourth film layers (132,134) positioned adjacent top and bottom sides respectively of the mesh layer (130) and secured thereto.
- The prosthesis according to claim 15, wherein the mesh layer (130) and third and fourth film layers (132,134) of the second biocompatible structure (140) are comprised of absorbable materials.
- The prosthesis according to claim 16, wherein the mesh layer (130) is comprised of a copolymer of lactide and glycolide, and the third and fourth film layers (132,134) are comprised of polydioxanone.
- An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect, comprising:a first composite structure (115) including at least one layer of a non-absorbable material, the first composite structure having a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and having an outer periphery;a second structure having an outer peripheral edge;a reinforcing element having an outer periphery positioned between the first and second structures, and having a stiffness greater than that of the first and second structures;wherein the second structure is coupled to the first structure (115) substantially only at their respective peripheries,characterized in that said second structure has a reinforced central region (136b) and said prosthesis further comprises at least one pulling element (120b,121b) coupled to the reinforced central region of the second structure.
- The prosthesis according to claim 18, having a substantially circular overall shape.
- The prosthesis according to claim 18 or 19, wherein the reinforcing element has an outer circumferential ring (180) lying in a first horizontal plane and an inner circumferential ring (182) lying in a second horizontal plane spaced apart from the first horizontal plane, and a plurality of spoke elements (184) extending between the inner and outer circumferential rings.
- The prosthesis according to any of claims 18 to 20, wherein the first composite structure further comprises first and second absorbable film layers positioned adjacent top and bottom sides of the non-absorbable layer.
- The prosthesis according to claim 21, wherein the non-absorbable layer is a mesh layer.
- The prosthesis according to claim 22, wherein the first composite structure further includes an absorbable layer positioned adjacent a bottom side of the first film layer.
- The prosthesis according to claim 18, wherein the central region of the second structure is reinforced by a ring element located therein.
- The prosthesis according to claim 18, wherein the second composite structure is comprised of absorbable materials.
- The prosthesis according to claim 22, wherein the mesh is comprised of polypropylene and the first and second film layers are comprised of polydioxanone.
- The prosthesis according to claim 18, wherein the second structure is further comprised of a mesh layer and third and fourth film layers positioned adjacent top and bottom sides of the mesh layer.
- The prosthesis according to claim 18, wherein the reinforcing element is comprised of an absorbable material,
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